Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2022-08-30

Brief Summary

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The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.

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Detailed Description

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Conditions

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Metabolic Bone Disease Transplant-Related Disorder Secondary Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Testing a single group of participants who are first time liver transplant candidates.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vertebral fracture assessment

Study participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment..

Group Type OTHER

Dual x-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

DEXA is a means of measuring bone mineral density (BMD) using spectral imaging. Two X-ray beams, with different energy levels, are aimed at the bones. Soft tissue absorption is subtracted out, then the bone mineral density (BMD) can be determined from the absorption of each beam by bone.

Vertebral Fracture Assessment

Intervention Type OTHER

Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.

Interventions

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Dual x-ray absorptiometry

DEXA is a means of measuring bone mineral density (BMD) using spectral imaging. Two X-ray beams, with different energy levels, are aimed at the bones. Soft tissue absorption is subtracted out, then the bone mineral density (BMD) can be determined from the absorption of each beam by bone.

Intervention Type DIAGNOSTIC_TEST

Vertebral Fracture Assessment

Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.

Intervention Type OTHER

Other Intervention Names

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DEXA Bone mineral density

Eligibility Criteria

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Inclusion Criteria

* First time liver transplant candidates deemed too early for liver transplant
* 24 hour urine Creatinine clearance of \> 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance \>60mg/dl

Exclusion Criteria

* Patients with prior solid organ transplantation
* Liver/kidney combination will be excluded
* Patients with 24 hr. urine creatinine clearance \< 40mL/minute
* Patients who have been on osteoporosis medications - Bisphosphonates \[Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)\] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years
* Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months
* Underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes